The policy is aimed at helping ensure the industry complies with existing regulations, said AHPA.
“FDA’s current position on the lawful status of CBD shouldn't be misinterpreted to mean that FDA does not regulate supplement or food products that contain hemp or CBD,” said Michael McGuffin, AHPA’s President. “Hemp and CBD companies should maintain compliance with established regulations for dietary supplement and food products to ensure quality and safety.”
According to FDA’s reading of federal law, CBD is not a legal dietary ingredient because it has previously been researched as a drug before promoters started bring CBD-containing supplements to the market. Despite this, new CBD products are launching every week, and, according to reports, there are over 1,400 SKUs marketed as CBD supplements or CBD oil supplements in the US.
Scott Gottlieb, MD, the outgoing FDA commissioner, announced recently that the Agency would explore the initiation of a rule making procedure on cannabidiol (CBD), with the goal of creating “an appropriately efficient and predictable regulatory framework for regulating CBD products.”
AHPA’s guidance policy was “developed to encourage industry to be mindful of the federal regulations that apply to these product categories, notwithstanding FDA’s ongoing review of the status of CBD and potential pathways for lawful addition of CBD to food and dietary supplements”, explained the association.
This means complying with the following federal regulations:
• food facility registration;
• current good manufacturing and good agricultural practice regulations;
• labeling requirements, including nutrition labeling, allergen disclosure, listing of required contact information, absence of drug claims, etc.;
• new dietary ingredient and food additive provisions, where applicable; and
• applicable obligations for timely submission to FDA of any received serious adverse event reports associated with their products;
The association’s guidance policies are developed to promote responsible commerce in herbal supplements by addressing a variety of labeling and manufacturing issues.
“These policies reflect the consensus of AHPA members and Board of Trustees. AHPA encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices,” states AHPA.
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